EBM - Diagnostic

Dr. dr.Juliandi Harahap, MA, FISPH, FISCM

Departemen Ilmu Kedokteran Komunitas

FK USU
 Evidence-Based Medicine

See a patient Ask a question Seek the best evidence

Monitor the Apply the evidence Appraise that evidence

change
Critical Appraisal - Worksheet for critical appraisal
- Software : CAT Maker
  Main area of clinical objectives:
 1. Diagnosis

 2. Prognosis

 3. Therapy/Treatment

 4. Risk/Harm

  Others:
 Systematic Review and Meta-analysis

 Clinical Guidelines

 Clinical Decision Making etc.

 Untuk menegakkan diagnosis diperlukan uji
diagnosis:
 Pemeriksaan klinis
 Pemeriksaan lab sederhana

 Pemeriksaan lain yg lbh canggih

 Uji diagnostik bisa dilakukan scr

 bertahap (serial): mis test tuberkulin dahulu baru
foto thorak
 Paralel: bbrp pemeriksaan dilaksanakan sekaligus.
 Uji diagnostik yg ideal: uji yg memberi hasil
positif pd semua subjek yg sakit dan
memberikan hasil negatif pd semua subjek yg
tidak sakit.

 Tetapi ada kemungkinan diperoleh hasil uji

positif pd subjek yg sehat (false posititive) dan
hasil negatif pd subjek yg sakit (false negative).
 Prinsip dasar uji diagnostik:
 Uji diagnostik baru hrs memberi manfaat yg lebih
dibanding uji diagnostik yg sdh ada.
 Lebih sederhana/mudah, murah dan tidak invasif
 Dpt mendiagnosa pd fase lebih dini
 Uji diagnostik bbtk tabel 2x2:

Penyakit
Hasil uji Ya Tidak Jlh
Ya PB PS PB+PS
Tidak NS NB NB+NS
Jlh PB+NS PS+NB total
PB=positif benar ; PS = positif semu ; NS = negatif semu ; NB = negatif benar
SENSITIVITAS dan SPESIFISITAS
BAKU EMAS
UJI Positif Negatif Jlh
Positif A B A+B
Negatif C D C+D
Jlh A+C B+D A+B+C+D
TABEL 2X2 HASIL UJI DIAGNOSTIK YAITU HASIL YG DIPEROLEH DGN UJI YG
DITELITI DAN DGN HASIL PD PEMERIKSAAN DGN BAKU EMAS.

Sensitivitas = A : (A+C)
Spesifisitas = D : (B+D)
Nilai prediksi positif (Positive Predictive Value ) = A : (A+B)
Nilai prediksi negatif (Negative Predictive Value) = D : (C+D)
 PRE-TEST PROBABILITY = PREVALENCE = (A+C ) /
(A+B+C+D)

LR = LIKELIHOOD RATIO
 LR+ = SENSITIVITY/(1-SPESIFICITY)
 LR- = (1- SENSITIVITY)/SPESIFICITY

 PRE TEST ODDS = PREVALENCE : ( 1- PREVALENCE)

 POST TEST ODDS = PRE TEST ODDS X LR
 POST TEST PROBABILITY = POST TEST ODDS : (1 +
POST TEST ODDS)
 Sensitivitas:
 memperlihatkan kemampuan alat diagnostik utk
mendeteksi penyakit.
 Kemungkinan bahwa hasil uji diagnostik akan positif
bila dilakukan pd sekelompok subjek yg sakit.
 Spesifisitas
 Menunjukkan kemampuan alat diagnostik utk
menentukan bahwa subjek tidak sakit
 Kemungkinan bahwa hasil uji diagnostik akan negatif
bila dilakukan pd sekelompok subjek yg sehat.
 Positive Predictive Value:
 Probabilitas seseorang menderita penyakit apabila uji
diagnostiknya positif.
 = A : (A+B)

 Negative Predictive Value:

 Probabilitas seseorang tidak menderita penyakit
apabila uji diagnostiknya negatif.
 = D : (C+D)
 Likelihood ratio:
 Probabilitas dari hasil test pad orang yang menderita
penyakit dibandingkan dengan probabilitas dari hasil
test pada orang yang tidak menderita penyakit.

 Likelihood ratio ini menunjukkan berapa kali

kemungkinan suatu hasil test dijumpai pada orang
yang menderita penyakit dibandingkan dengan orang
normal.
 POSITIVE LIKELIHOOD RATIO (LR+)
Menunjukkan berapa besar kemungkinan suatu test
memberikan hasil positif pada orang yang sakit
dibandingkan pada orang sehat.
= { a/(a+c)} / {b/(b+d)}
= SENSITIVITY / (1- SPECIFICITY)

 NEGATIVE LIKELIHOOD RATIO (LR-)

Menunjukkan berapa besar kemungkinan suatu test
memberikan hasil negatif pada orang yang sakit
dibandingkan pada orang sehat.
= { c/(a+c)} / {d/(b+d)}
= (1- SENSITIVITY ) / SPECIFICITY
 Makna likelihood ratio
 dapat menunjukkan adanya kemungkinan
perubahan pre test ke post test probablity dari
suatu diagnostic test.
 >10 or < 0.1 : menunjukkan perubahan besar

 5-10 and 0.1-0.2: menunjukkan perubahan sedang

 2-5 and 0.5-0.2 : menunjukkan perubahan kecil

 1-2 and 0.5-1 : menunjukkan perubahan sedikit

atau tidak ada
Kemampuan suatu test yang valid, bila dapat merubah
pendapat kita dari apa yang kita pikirkan sebelum test
(pretest probability) ke apa yang kita pikirkan setelah
test (postest probability)

Test diagnostic akan lebih berguna bila test tsb

menghasilkan perubahan yang besar (big changes) dari
pretest probability ke postest probability.
 Cth 1:

Penyakit
Limfoma Non Jlh
limfoma
Hasil uji Positif 65 30 95
Negatif 35 70 105
Jlh 100 100 200

Sensitivitas = A : (A+C) = 65 : 100 = 65%

Spesifisitas = D : (B+D) = 70 : 100 = 70%

Uji diagnostik terbaik adalah uji diagnostik yg

mempunyai sensitivitas dan spesifisitas yg tertinggi
 Cth 2:

Histopatologi
Ca Non Ca Jlh
Positif 13 4 17
Mammografi Negatif 3 28 31
Jlh 16 32 48

PRE-TEST
LR+: LR-:
SENSITIVITY: SPESIFICITY: PROBABILITY
SENS/ (1-SENS)
A/(A+C) D/(B+D) = PREVALENCE:
(1-SPEC) /SPEC
(A+C ) / (A+B+C+D)

(13/16)X100% 1-(13/16)
(28/32)X100% (13/16) 16/48
/(28/32)
/(1-28/32)
= 81,25%
=87,5% =6,5 = 33,3%
=0,21
 PRE TEST ODDS= POST-TEST PROBABILITY=
POST TEST ODDS=
PREVALENCE: POST TEST ODDS:
PRE TEST ODDS X LR+
(1-PREVALENCE) (1+POST TEST ODDS)

0,5 X 6,5 3,25 : (1+3,25)

(16/48) : (1-16/48)
= 0.764
= 3,25 = 76,4%
= 0,5

Pretest probability Post test probability

33.3% 76.4%

 Diagnostic tests that produce big changes from pretest to post-test

probabilities are important and likely to be useful to us in our practice
 Worksheet for

Diagnosis
DIAGNOSIS WORKSHEET
Citation:

Are the results of this diagnostic study valid?

Was there an independent, blind comparison with a

reference (“gold”) standard of diagnosis?
Was the diagnostic test evaluated in an appropriate
spectrum of patients (like those in whom it would be
used in practice)?
Was the reference standard applied regardless of the
diagnostic test result?
Was the test (or cluster of tests) validated in a second,
independent group of patients?
Are the valid results of this diagnostic study important?
SAMPLE CALCULATIONS
Target disorder Totals
(iron deficiency anemia)
Present Absent
Diagnostic Positive 731 270 1001
test result (< 65 mmol/L) a b a+b
(serum Negative 78 1500 1578
ferritin) ( 65 mmol/L) c d c+d
Totals 809 1770 2579
a+c b+d a+b+c+d
Sensitivity = a/(a+c) = 731/809 = 90%
Specificity = d/(b+d) = 1500/1770 = 85%
Likelihood ratio for a positive test result = LR+ = sens/(1-spec) = 90%/15% = 6
Likelihood ratio for a negative test result = LR - = (1-sens)/spec = 10%/85% = 0.12
Positive Predictive Value = a/(a+b) = 731/1001 = 73%
Negative Predictive Value = d/(c+d) = 1500/1578 = 95%
Pre-test probability (prevalence) = (a+c)/(a+b+c+d) = 809/2579 = 32%
Pre-test odds = prevalence/(1-prevalence) = 31%/69% = 0.45
Post-test odds = pre-test odds  LR
Post-test probability = post-test odds/(post-test odds +1)
Can you apply this valid, important evidence about
a diagnostic test in caring for your patient?

Is the diagnostic test available, affordable, accurate, and precise in your

setting?
Can you generate a clinically sensible estimate of your patient’s pre-test
probability (from personal experience, prevalence statistics, practice
databases, or primary studies)?
Are the study patients similar to your own?
Is it unlikely that the disease possibilities or probabilities have changed
since the evidence was gathered?
Will the resulting post-test probabilities affect your management and help
your patient?
Could it move you across a test-treatment threshold?
Would your patient be a willing partner in carrying it out?
Would the consequences of the test help your patient?

Additional notes:
 Software: CAT Maker……
Thank you…..